Green Tea Extract in Preventing Cervical Cancer in Patients With Human Papillomavirus and Low-Grade Cervical Intraepithelial Neoplasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00303823
Recruitment Status : Completed
First Posted : March 17, 2006
Results First Posted : August 17, 2012
Last Update Posted : May 5, 2015
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions: Cervical Cancer
Cervical Intraepithelial Neoplasia Grade 1
Human Papilloma Virus Infection
Interventions: Drug: placebo
Dietary Supplement: defined green tea catechin extract
Other: laboratory biomarker analysis

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Polyphenon E (Defined Green Tea Catechin Extract) Patients receive oral Polyphenon E daily for 16 weeks
Placebo Patients receive oral placebo once daily for 16 weeks

Participant Flow:   Overall Study
    Polyphenon E (Defined Green Tea Catechin Extract)   Placebo
STARTED   50   48 
COMPLETED   35   38 
NOT COMPLETED   15   10 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Polyphenon E No text entered.
Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
   Polyphenon E   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 50   48   98 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   50   48   98 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 28.48  (8.78)   28.27  (8.05)   28.28  (8.39) 
[Units: Participants]
Female   50   48   98 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
United States   50   48   98 

  Outcome Measures

1.  Primary:   Complete Response - Clearance of Oncogenic Human Papillomavirus (HPV) and Complete Colposcopic, Histologic and Cytologic Clearance of Disease   [ Time Frame: 4 months ]

2.  Primary:   Partial Response - Clearance of Oncogenic HPV With Evidence of Low Grade Cervical Intraepithelial Neoplasia   [ Time Frame: 4 months ]

3.  Primary:   No Response - Persistent Oncogenic HPV Positivity, With or Without Evidence of Low Grade Cervical Intraepithelial Neoplasia   [ Time Frame: 4 months ]

4.  Primary:   Progression - Persistent Oncogenic HPV Positivity, With Evidence of Progression to Worsening Cervical Intraepithelial Neoplasia or Invasive Cancer   [ Time Frame: 4 months ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: H-H. Sherry Chow, Ph.D.
Organization: The University of Arizona
phone: 520-626-3358

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: National Cancer Institute (NCI) Identifier: NCT00303823     History of Changes
Other Study ID Numbers: NCI-2009-00893
NCI-2009-00893 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
HSC 05-40
05-0144-01 ( Other Identifier: Arizona Cancer Center - Tucson )
UAZ03-1-02 ( Other Identifier: DCP )
P30CA023074 ( U.S. NIH Grant/Contract )
N01CN35158 ( U.S. NIH Grant/Contract )
First Submitted: March 15, 2006
First Posted: March 17, 2006
Results First Submitted: July 13, 2012
Results First Posted: August 17, 2012
Last Update Posted: May 5, 2015